Table 1.
Overview of clinical data for aripiprazole in major depressive disorder
| Study | Aripiprazole starting dose (permitted adjustment), mg | Comparator | Duration | Total n | Primary endpoint | Primary publication |
|---|---|---|---|---|---|---|
| CN138–139 | 5 (2–20) | Placebo | 6 weeks | 362 | Mean change in MADRS from baseline to Week 6: −8.8 vs −5.8, p < 0.001 | Berman et al 2007 |
| CN138–163 | 5 (2–20) | Placebo | 6 weeks | 381 | Mean change in MADRS from baseline to Week 6: −8.5 vs −5.7, p = 0.001 | Marcus et al 2008 |
| CN138–462 | 10 (10–20) | N/A | 15 days | 38 | No meaningful effects on the pharmacokinetic parameters for venlafaxine (Cmax, Cmin, Tmax, AUC(TAU)) when administered alone and co-administered with aripiprazole | Boulton et al in press |
| CN138–463 | 10 (no adjustment) | N/A | 15 days | 25 | No meaningful effects on the pharmacokinetic parameters for escitalopram (Cmax, Cmin, Tmax, AUC(TAU)) when administered alone and co-administered with aripiprazole | Boulton et al in press |
| CN138–164 | Continuation dose from Studies CN138–139 and CN138–163 | Placebo | 52 weeks | 930 | Incidence of treatment-emergent adverse events | Berman et al 2008 |
| CN138–165 | 5 (2–20) | Placebo | 6 weeks | 349 | Incidence of treatment-emergent adverse events | Unpublished data |